Clinical Trial Effect….

The only treatment currently available for celiac disease is a gluten free diet. For most celiac drugs in clinical trials today, the trial participants are supposed to maintain their gluten free diet. Often these patients feel better during the clinical trial whether they are in the drug or placebo arm of the study. Often the clinical trial participant will feel better over time because they have improved the quality of their gluten free diet either through better nutrition or better adherence to the gluten free diet. This is called the “clinical trial effect”.

Moving forward researchers have to control for the “clinical trial effect”. Moving forward, you may see more trials that have requirements for ongoing gluten consumption. It seems as though the trial will test your gluten exposure using “GIP” testing or Gluten Immunogenic Peptide, typically through urine. This tests will determine how much gluten is being consumed on a regular basis. Researchers will then provide you with a low level of gluten exposure to counteract the “clinical trial effect” to help maintain the integrity of their study.

Note, this is not like a gluten challenge where they offer a large amount of gluten over a short period of time. This is low level gluten exposure to mimic the gluten exposure in regular life. A gluten challenge may or may not change the celiac blood tests, but low level gluten exposure might. Low level gluten exposure over time can also induce far more damage than one or two significant glutenings over an extended period of time.

By ensuring some level of exposure, the researchers are certain the drug they are testing prevents damage. With the new FDA guidelines that will require endoscopy before and at the end of the trial, we can be sure that the drug actually protects the small intestine from damage. Symptom alleviation is one thing, but protecting my small intestine during minor exposure is really the beginning of a cure.

If you think you are 100% gluten free, try doing GIP tests on a daily basis for a while to see what your gluten exposure really looks like. GlutenDetect offers these tests. #glutensensitivity #glutenfreerecipes #glutenfree #celiacdisease #celiac

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